ICM enables seamless end-to-end continuous manufacturing processes that incorporate API formation steps with final drug product formulation. By eliminating all the stops-and-starts that make current manufacturing processes time- and cost-inefficient, we are able to attain all the benefits associated with continuous manufacturing. Important underlying principles include continuous flow, an end-to-end strategy, a systems approach, and an integrated control system. The following case study, based on pilot studies performed at CONTINUUS’s facility, demonstrate how ICM can provide advantages over an already well-established and optimized batch process (click here for video of pilot line).
Case Study for ICM
The integrated nature of ICM processes eliminates points of human exposure – process material and intermediates remain in situ, and are transported across the different unit operations through automated and closed processes. This is particularly beneficial for manufacturers of high potency compounds, where containment challenges are significant. Furthermore, the small in-process volumes characteristic of ICM systems further improve operator safety.
Processes with unstable or explosive intermediates can also benefit significantly from ICM implementation. This is because with ICM processes, these intermediates are generated on demand, and are immediately consumed (i.e., they are not isolated and then manually transported to the next step), reducing the build-up of such dangerous materials.
Due to its unique features, such as its use of novel continuous technologies, ICM can provide advantages across the entire supply chain (see figure below).
Supply Chain Advantages of ICM